Regulatory Focus™ > News Articles > Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case

Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case

Posted 04 February 2015 | By Michael Mezher 

Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case

A prominent Indian court has ruled that India's patent office erred when it invalidated a patent application owned by the pharmaceutical company Gilead, giving the company another chance to save its patent on the hepatitis C drug Sovaldi while the patent office revisits the application.

Monday, Regulatory Focus reported the outcome and major themes of the court’s decision. In this article Focus will take a closer look at the facts of the case and the court’s judgment.


On 13 January 2015, India’s Patent Office rejected Gilead's patent application for a compound produced by the body as it metabolizes Sovaldi, also known as sofosbuvir. Gilead said the patent rejection would not change its plans to sell the drug in India.

Gilead’s patent application was challenged by pre-grant oppositions filed by Natco Pharma and I-MAK, a nonprofit advocacy organization.

In its decision to reject Gilead’s patent application (6087/DELNP/2005), the Patent Office observed that though changes described in Gilead's application make the compound “novel and inventive,” the application does not prove the compound's enhanced “therapeutic efficacy” compared to its “closest prior art,” a compound covered by patent WO2001/92282 and referred to as "D1" by the Patent Office.

The challenge for Gilead, according to the Patent Office, was that it needed to show that its compound was therapeutically superior to the "D1" compound. However, because the "D1" compound was never produced or marketed, Gilead did not include any data comparing the two substances in its patent application.

Following the rejection, Gilead filed a petition challenging the procedure followed by the Patent Office. On 30 January 2015, the Delhi High Court heard Gilead’s petition in the case of Gilead Pharmasset, LLC vs. Union of India & ANR, Case No. WP(C) 687/2015.

Analysis of the Case

Gilead, the petitioner in the case, was represented by Ms. Pratibha Singh; the government of India was represented by Mr. Manik Dogra. Advocates for the opponents (Sankalp Rehabilitation Trust, BDR Pharma, Natco Pharma and I-MAK) were also present in the hearing.

The judgment notes that the Sankalp Rehabilitation Trust and BDR either “intend to file or have filed, in the interregnum,” oppositions to Gilead’s patent application.

In the context of Indian patent law, "oppositions" are documents containing a challenge to the patent application.

In its petition, Gilead argued there was “a complete breach of principles of natural justice” by the Patent Office in how it took into account, and used, materials supplied by the opposition.

Singh argued that the Patent Office borrowed too heavily from the pre-grant oppositions, and even reproduced entire sections of the oppositions—including typographical errors—in its decision. Furthermore, Singh submitted that while Gilead received the documents filed by opponents to Gilead's application, Gilead itself was not given a chance to challenge the claims made by opponents.

During the hearing, Dogra defended the procedure the Patent Office followed. He argued the office had properly provided notice of the pre-grant oppositions, and had not relied on the oppositions filed by the patent application's opponents when making its decision.

The Ruling

In his ruling, Justice Rajiv Shakdher determined that sufficient notice of the pre-grant oppositions was not given to Gilead before the hearing by the Patent Office. Shakdher said the Patent Office supplied Gilead with the pre-grant oppositions before the hearing under Section 14 of the Patents Act.

In plain terms, Section 14 requires the patent office to communicate "expeditiously" any objections it has with the patent application to the company—in this case, Gilead. That company is then able to meet with patent officials to discuss those objections.

However, Gilead had argued that another obligation under the Patents Act, known as Section 25, had not been met. That section requires the Patent Office to notify a company of "the extent and scope of objections" raised by outside parties.

Section 25(4): Opposition to the patent — On receipt of the recommendation of the Opposition Board and after giving the patentee and the opponent an opportunity of being heard, the Controller shall order either to maintain or to amend or to revoke the patent.

Shakdher agreed with Gilead's argument that it had not been given sufficient opportunity to respond to the oppositions, saying: "No notice was issued to [Gilead] with regard to the applications filed under Section 25 of the [Patents Act]. Therefore … there was no clarity as to the extent and scope of objections, which [Gilead] was required to meet while pressing ahead with its request for grant of patent.”

Shakdher said the Patent Office could therefore not show that it had been impartial—free from "influence," as he wrote—in adjudicating the patent.

The judgment sets aside the disputed decision, and requires the Patent Office to grant Gilead a hearing addressing both the opposition and Patent Office’s objections.


Delhi High Court Decision

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